Peripheral Physiological Measures as Determinants of Pain Risk

Neuralgia Clinical Trial

— DOLORiskWP51  

Official title:

DOLORisk: Understanding Risk Factors and Determinants for Neuropathic Pain - Peripheral Physiological Measures as Determinants of Pain Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02985294
• Other study ID #: Neuroscience Technologies
• Status: Recruiting
• Start date: April 2016
• Est. completion date: April 2020

Study information

• Verified date: August 2018
• Source: Neuroscience Technologies SLP, Barcelona
• Contact: Romà Solà, MD
• Phone: 0034 934020164
• Email: rsola[@]nsc-tec.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study evaluates peripheral nervous system function using Multiple Excitability Measures (MEM) to obtain "electrophysiological pain phenotypes"

Description:

Using MEM for peripheral sensory and motor axons we want to identify a set of excitability measures that:

1. Correlate with parameters of clinical pain and of pain processing in existing pain patients (cross sectional study), with the aim to obtain an objective Pain Biomarker.

2. Predict development of neuropathic pain in susceptible patients (longitudinal study). Neuropathic Pain Predictor for patients:

i. Undergoing surgical procedures associated with a relatively high risk of developing neuropathic pain such as thoracotomy and hernia repair ii. Planning to start chemotherapy with potentially neurotoxic agents such as vincristine

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic peripheral neuropathic pain

• Painless Patient with risk to develop neuropathic pain (post-surgery, chemotherapy-induced)

Exclusion Criteria:

• Minors

Related Conditions & MeSH terms

• Chemotherapy Effects
• Nervous System Diseases
• Neuralgia
• Peripheral Nerve Injuries
• Peripheral Nervous System Diseases
• Polyneuropathies

Intervention

Other:
• Multiple Excitability Measures of peripheral nerves
The technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and `threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual

Locations

Country	Name	City	State
Spain	Neuroscience technologies	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Neuroscience Technologies SLP, Barcelona	Institut National de la Santé Et de la Recherche Médicale, France, University of Aarhus, University of Dundee, University of Oxford

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrophysiological pain phenotypes using MEM. Pain biomarker	Correlate with parameters of clinical pain and of pain processing in existing pain patients	Single assessment (cross sectional study) at the first and only visit
Primary	Electrophysiological pain phenotypes using MEM. Pain predictor	Predict development of neuropathic pain in susceptible patients	Single assessment at baseline, before any procedure (surgery/chemotherapy)

External Links

•   Official Consortium web site